BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°

    MDR report key: 7883244 · Received September 17, 2018

    Report

    Report Number
    0009610622-2018-01051
    Event Type
    Malfunction
    Date Received
    September 17, 2018
    Date of Event
    August 20, 2018
    Report Date
    November 15, 2018
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    UDI-DI
    04546540375070
    PMA / PMN Number
    K034002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT THAT TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° WAS ALLEGED OF 'LABELLING - MISLABELLING' COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE FAILURE WAS CAUSED BY A MIX-UP IN THE HOSPITAL, PROBABLY DURING THE CHECKING PHASE OF THE DEVICES. INDEED, THE TRACING OF THE TWO LOT NUMBERS SHOWS THAT A TRANSACTION WAS MADE TO THE CUSTOMER FOR LOT K0592BB ON THE 14TH OF AUGUST 2018, AND ANOTHER ONE FOR LOT K04C818 WAS MADE ON THE 13TH OF AUGUST 2018. THE TWO LOTS WERE MANUFACTURED 6 DAYS APART, WHICH EXCLUDES A MIX-UP AT THE MANUFACTURING SITE. A REVIEW OF THE STICKER HISTORY WAS PERFORMED: FOR LOT # K0592BB: 46 DEVICES WERE RELEASED ON THE 20 TH OF JULY 2018. DURING MANUFACTURING, 47 BOX STICKERS WERE PRINTED, 46 WERE STUCK ON THE PRODUCT BOXES, 1 WAS ARCHIVED. IT IS THUS NOT POSSIBLE FOR THE STICKER OF LOT# K0592BB TO HAVE ENDED UP ON THE BOX OF LOT# K04C818. FOR LOT # K04C818: 47 DEVICES WERE RELEASED ON THE 26TH OF JULY 2016 . DURING MANUFACTURING, 48 BOX STICKERS WERE PRINTED, 47 WERE STUCK ON THE PRODUCT BOXES, 1 WAS ARCHIVED. IT IS THUS NOT POSSIBLE FOR THE STICKER OF LOT# K04C818 TO HAVE ENDED UP ON THE BOX OF LOT# K0592BB. FURTHERMORE, A REVIEW OF THE SALES SHOWS THAT THE TWO LOTS WERE DISTRIBUTED TO THE SAME HOSPITAL. THE TRANSACTION DATES FOR THE TWO LOTS WERE ONE DAY APART, WHICH PRESSES THE FACT THAT THE MIX UP COULD PROBABLY HAVE HAPPENED IN THE HOSPITAL DURING CHECKINGS OF THE DEVICES. THE DEVICE INSPECTION REVEALED THE FOLLOWING: A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    THE GAMMA-NAIL WAS WRONGLY PACKED AND IT WAS WRONGLY LABELED. INSTEAD OF A 125° GAMMA-NAIL THERE WAS A 130° GAMMA-NAIL INSIDE. IT WAS LABELED AS 125° NAIL.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE GAMMA-NAIL WAS WRONGLY PACKED AND IT WAS WRONGLY LABELED. INSTEAD OF A 125° GAMMA-NAIL THERE WAS A 130° GAMMA-NAIL INSIDE. IT WAS LABELED AS 125° NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721146 TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K0592BB 04546540375070

    Patients

    Seq Age Sex Outcome Treatment
    1 Other